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Build FDA-compliant software, faster.

Build FDA-compliant software, faster.

The only AI platform that supports you from day zero.

Join thousands of users who rely on Sammy to simplify compliance, save $4,000/ month on regulatory guidance, and get their SaMD to market faster.

The only AI platform that supports you from day zero.

The only AI platform that supports you from day zero.

Book a demo

Free Trial

This is the future of SaMD

This is the future of SaMD

This is the future of SaMD

Let Sammy streamline your compliance journey, so you can focus on what matters most - innovating for patients. Sammy makes compliance quick & simple, so you can focus on building life-saving software.

Let Sammy streamline your compliance journey, so you can focus on what matters most - innovating for patients.

AI-Powered Document Generation

Say goodbye to manually generating documents. Spend your valuable time focusing on your user requirements, and let Sammy handle the rest.

Already got those key planning documents generated? No worries - We'll identify the compliance gaps to keep you on track throughout your development journey.

Say goodbye to manually generating documents. Spend your valuable time focusing on your user requirements, and let Sammy handle the rest.

Automated Change Management

Let Sammy worry about handling all those documentation updates and cascading references.

Sammy seamlessly integrates into your workflow. Just connect your code repo & continue to work as normal to update your device. Any update to your device will be automatically updated in your documentation - yes it can be that easy.


Let Sammy worry about handling all those documentation updates and cascading references.

Your very own AI Regulatory
Co-pilot

Ask, and you shall receive… 24/7, and without those billable hours.
Your very own AI-regulatory consultant, giving you instant access to expert advice on FDA guidance. Sammy is informed by the latest standard updates and up-to-date FDA regulations.

Ask, and you shall receive… 24/7, and without those billable hours.

Integrated with all your favourite tools

Integrated with all your favourite tools

Integrated with all your favourite tools

✅ Continue to work as normal

✅ Focus on development

✅ Compliant from Day 1

4,000+

4,000+

pages of regulation read & understood for you

$2,000

$2,000

avg. per month back in your pocket

90%

90%

reduction in SaMD development complexity

80%

80%

reduction in manual documentation

Don't miss out.

Join the SaMD Revolution now.

Don't miss out.

Join the SaMD Revolution now.

Don't miss out.

Join the SaMD Revolution now.

Got your attention? Let’s take this relationship to the next level. Drop your email below and we'll be in touch with the future of SaMD development.

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